Overuse of blood components in the hospital is an identified medical problem and is addressed by a new medical field termed “blood management.” Nationally, greater than 50% of transfusions administered do not meet hospital guidelines, thereby resulting in over-treatment of large numbers of patients with a biologic product associated with significant risk and expense. These risks include, but are not limited to, cardiac overload, infection, increased length of hospital stay, and death. Risk can increase in a dose-dependent manner, and even a small amount of blood received, such as transfusion of one unnecessary unit of blood, is considered an undesirable event.
Despite these risks, blood transfusion is the most common procedure in hospitals, and blood transfusion has increased in U.S. hospitals by 140% over the last 10 years. Approximately 17 million transfusions of red blood cells are performed annually in the U.S. The direct cost for the blood component and infusion accounts for about 5% of a hospital's budget. For a single transfusion of red blood cells, the direct cost is about $1,000. However, when the cost associated with adverse events is considered (increased length of stay, infection, etc.), the true cost doubles to $2,000 to $2,500 per transfusion.
Blood management is defined as the appropriate use of blood components with a focus on minimizing blood use and currently is directed at in-hospital transfusion practice. This focus fails to consider the significant population of patients who present for non-emergent scheduled surgeries routinely associated with high blood loss, such as cardiovascular and orthopedic procedures, with low blood counts (anemia) and, thus, have a predictable risk of receiving allogeneic donor blood. Other surgeries associated with high blood loss include gastrointestinal surgery, gynecologic oncology surgery, vascular surgery, urologic surgery, neurosurgery, and others.
Approximately 2.5 million patients in the United States undergo non-emergent high blood loss surgeries annually, and up to 40% are anemic on presentation to the hospital. Anemia prevalence varies by surgical demographic group with 35% anemia prevalence in joint replacement patients and 60% anemia prevalence rate in cardiac valve replacement patients. Current practice is to conduct a preoperative history and physical examination with lab work, including hemoglobin evaluation, in the week prior to surgery. The timeframe for this assessment does not allow for either etiology determination or treatment of anemia prior to surgery, and surgery is cancelled for only profoundly anemic patients. As many as fifty five (55%) percent of non-emergent surgical patients have no preoperative anemia screening. The screening process is generally not standardized, and there is no expectation that treatable anemia be corrected before surgery is performed. Prospective risk assessment for transfusion, irrespective of anemia, is not performed to stratify surgical patients into high or low risk for receipt of stored blood and, as such, methods to decrease blood loss are generally not employed for high risk patients.
New protocols and tools are needed to effectively assess and treat patients scheduled for high blood loss procedures or having other indications that increase the likelihood of transfusion. These protocols and methods need to be reliable, reproducible, and measurable from a risk reduction and financial savings standpoint.